Duns Number:105932508
Device Description: Combo Kit: Pink Breast Cancer Awareness Nurse Kit: 30-510-014-A Gem-Scope, Adult, Black, B Combo Kit: Pink Breast Cancer Awareness Nurse Kit: 30-510-014-A Gem-Scope, Adult, Black, Breast Cancer Awareness with Extra Diaphragm: 60-840-210-HP 2.5 V Standard Otoscope w/specula: 60-402-210-1 Penlight, Disposable, Pink, With Pupil Gauge, Single: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-310 Utility scissors 5.5", stainless steel with neon pink handle: 80-001-210 Pink Paper Mate Write For Hope Pen - Black Ink: 80-174-000 Kelly forceps, 5.5", straight, stainless steel: Nurse Kit Pocket Organizer, White, Latex Free: 2 Velcro Tab, Fuchsia, Latex Free
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
80-510-014-OTO-L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ERA
Product Code Name
Otoscope
Public Device Record Key
631f80cb-a446-425f-a7f8-5e33f3bde94d
Public Version Date
September 23, 2022
Public Version Number
5
DI Record Publish Date
October 03, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 658 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 163 |